Regulatory Submissions

Did you know that many jurisdictions (e.g. (Australia, Saudi Arabia, Taiwan) offer fast track processes for devices which hold CE or US approvals. It’s essential to appreciate the opportunities presented by mutual or unilateral recognition of regulatory certifications.

Regulatory processes and requirements vary widely. The art is in understanding the underlying technical requirements and standards and matching these to the various regulatory processes. This then allows compilation of a single regulatory data set and definition of a regulatory strategy that is efficient and provides the quickest access to markets of interest.

Our leadership team has decades of experience in regulatory systems and the evolution of the global regulatory landscape. They are supported by a team of highly trained consultants with detailed knowledge of submission requirements and processes.

We can assist you with:

Regulatory Strategy for one or multiple markets

Pre-submission consultations with regulators including US and CHina FDA’s, Notified Bodies, Australian TGA.

Case Studies

One System, many sites. A US headquartered multi-national implant manufacturer had been marketing in Taiwan for more than ten years and had obtained multiple product approvals based on US FDA approvals. Rapid expansion over that period spanned had enlarged operations to more than 20 separate global manufacturing sites controlled by a single quality system. Taiwan […]